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K Number
K150468Device Name
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
Manufacturer
K2 Medical GmbH & Co. KG
Date Cleared
2016-02-29
(371 days)
Product Code
HAE
Regulation Number
882.4840Why did this record match?
Applicant Name (Manufacturer) :
**K2 Medical GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
Device Description
K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
The devices are available with the following features:
Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate
- with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
- with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
- different shaft overall length (6 " inch to 15 " inch) -
- different sizes (1mm to 6 mm)
- different angles (up 40°, up 90°, down 90° -
- without ejector or with different types of ejectors
- with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
- traditional style or with special cleaning channel
- traditional style or with opening mechanism (convertible, take-apart)
- with rotating shaft angled 90° and 40°
IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart
- in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
- with different length and jaw sizes
- angled and straight
- with closed jaw and with fenestrated jaws
- with smooth jaw and with teeth
Laminectomy Rongeurs with double action joints and strong handle
- Fulton Laminectomy Rongeurs -
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K Number
K120492Device Name
K2 MEDICAL VASCULAR CLAMPS
Manufacturer
K2 MEDICAL GMBH & CO. KG
Date Cleared
2012-04-30
(73 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
**K2 MEDICAL GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K2 Medical Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
Device Description
The K2 Medical Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - Some have ring handles with a ratchet closure to adjust the amount of tension applied to . the vessel for occlusion or partial occlusion. - Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross . action mechanism to apply tension to the vessel for occlusion. - The choice of iaw style depends on the surgeon's preference, based on the type and delicacy of . the vessel to be occluded. The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel. K2 Medical vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy. The instruments are offered in non-sterile condition.
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